OptraGate 2 757912WW

GUDID DVIV757912WW0

OptraGate 2 Regular Refill / 80

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Rubber dam, non-latex

• Primary Device ID: DVIV757912WW0
• NIH Device Record Key: 6221c94d-3835-4e97-86cf-dbb9d8efb1c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptraGate 2
• Version Model Number: 757912WW
• Catalog Number: 757912WW
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 80
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DVIV757912WW0 [Unit of Use]
HIBCC	DVIV757912WW1 [Primary]

FDA Product Code

• EIF: ACCESSORIES, RETRACTOR, DENTAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-27
• Device Publish Date: 2024-11-19

On-Brand Devices [OptraGate 2]

• DVIV757914WW0: OptraGate 2 Small Refill / 80
• DVIV757912WW0: OptraGate 2 Regular Refill / 80
• 07615208526455: OptraGate 2 Test Pack 2x1